Senior Medical Writer

San Diego, CA

  • Samumed is looking for a Sr. Medical Writer to join our Regulatory Affairs team.
  • The Sr. Medical Writer is responsible for writing, reviewing, and overseeing the production of clinical, non-clinical, and regulatory documents in support of drug development programs.

Specific Responsibilites

  • Working directly to support the clinical, non-clinical, and regulatory teams by authoring documents and managing the document review process
  • Participating in clinical study team and other appropriate development team meetings to provide input regarding deliverables, timelines, and process
  • Coordinating with project team leads regarding appropriate document content
  • Documents include but are not limited to: Protocols and protocol amendments, clinical study reports, Investigator brochures, annual reports and submission documents, pharmacology and PK reports, nonclinical summaries, summary documents, briefing documents, and regulatory responses

Requirements

  • Qualifications: Bachelor's degree in life sciences, RN, Master's degree in life sciences, PharmD or PhD preferred
  • Minimum 5 years of medical writing/regulatory experience in the biotech or pharmaceutical industry
  • The medical writer should be familiar with FDA and ICH guidelines and the current AMA Style Manual
  • Experience with regulatory submissions (IND, NDA, MAA, NDS, etc.) in eCTD format
  • Experience authoring /editing Clinical Study Reports and other clinical regulatory documents
  • Excellent written and oral communication and interpretive skills
  • High attention to detail, and excellent proofreading and editing skills
  • High‑level competence in pertinent software (e.g., Word, PowerPoint, EndNote)
  • Knowledge of the drug development process and general knowledge of applied clinical medicine and laboratory interpretation
  • Experience with small molecule drug development is preferred
  • Demonstrated ability in project management, with overlapping priorities and aggressive timelines

 


Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded.